Certifications Specialist

Seeking a Certificates Specialist to manage regulatory documentation and certification processes for pharmaceutical products in Japan.

Roles/Responsibilities

• Process Certificates of Pharmaceutical Product (CPP) and GMP compliance inspection applications to PMDA.
• Coordinate with contract manufacturing organizations (CMOs) and internal stakeholders to obtain:
• GMP certificates
• Manufacturing licenses
• Other required regulatory documentation
• Manage documentation requests, including:
• Letters of authorization
• Declarations
• Notarization and legalization processes
• Receive and route certificates via the PSS Certificate tool.
• Prepare performance dashboards and provide periodic updates to stakeholders.

Required skills

• 1-3 years of experience in a pharmaceutical regulatory or documentation role.
• Strong understanding of PMDA and MLHW submission processes and regulations.
• Experience in handling statutory documents and regulatory certifications.
• Proficiency in Japanese and basic English

About our client

A global leader in providing comprehensive regulatory solutions and services to the life sciences industry. Helping pharmaceutical, biotech, and medical device companies navigate the complex regulatory landscape, ensuring compliance and accelerating time-to-market for their products.